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PUBLIC LAW 87-781-.OCT. 10, 1962 Public Law 87-781

October 10, 1962 [S.1552]

Drug Amendments of 1962.

[76 STAT.

^

AN ACT To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to a s s u r e the safety, effectiveness, and reliability of drugs, authorize standardization of d r u g names, and clarify and strengthen existing inspection authority; and for other purposes.

Be it enacted by the Seriate and House of Representatives of the United States of America in Congress assembled, That this Act, divided into titles and sections according to the following table of contents, may be cited as the "Drug Amendments of 1962". T A B L E O F CONTENTS TITLE PART A

Sec. 101. Sec. 102. Sec. 103. Sec. 104. Sec. 105. Sec. 1,06. Sec. 107.

AMENDMENTS TO ASSURE SAFETY, B^FECTIVENESS, A N D RELIABILITY

Requirement of adequate controls in manufacture. Effectiveness and safety of n e w drugs. Records and reports a s to experience on new drugs. New drug clearance procedure. Certification of antibiotics. Records and reports a s to experience on antibiotics. Effective dates and application of part A. PART B

Sec. Sec. Sec. Sec.

111. 112. 113. 114.

I—DRUGS

STANDARDIZATION OF DRUG N A M E S

Review and designation of official names. Name to be used on d r u g label. Exclusion of cosmetics. Information to physicians. PART C

AMENDMENTS AS TO ADVERTISING

Sec. 131. Prescription d r u g advertisements. TITLE II — F ACT O R Y INSPECTION AND E F F E C T ON STATE

LAWS

Sec. 201. Factory inspection. Sec. 202. Effect on State laws. Sec. 203. Effective date. TITLE III—^REGISTRATION OF DRUG ESTABLISHMENT S AND P A T E N T

INFORMATION

Sec. 301. Findings and declaration. Sec. 302. Registration of producers of drugs. Sec. 303. T r a n s i t i o n a l provisions. Sec. 304. F a i l u r e to register. Sec. 305. Drugs from nonregistered establishments misbranded. Sec. 306. Samples of imported drugs. Sec. 307. Definitions. Sec. 308. Information on p a t e n t s for drugs.

TITLE I—DRUGS PART

A—AMENDMENTS TO ASSURE SAFETY, EFFECTIVENESS, AND RELJABILITY REQUIREMENT OF ADEQUATE CONTROLS I N MANUFACTURE

52 Stat. 1049.

SEC. 101. Clause (2) of section 501(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)) is amended to read as follows: " (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not

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